Journal of Pharmacy and Pharmacology 4 (2016) 359-365

doi: 10.17265/2328-2150/2016.07.010
D DAVID PUBLISHING

Impact of Pharmacist Insulin Management on

Hemoglobin A1c in Outpatient Hospital Clinic Setting

Danette Warner, Shauna Willeke and Jason Sturgeon

Department of Pharmacy, Licking Memorial Health System, Newark, 43055, Ohio, USA

Abstract: To assess the efficacy of pharmacist lead insulin management in improvement of HbA1c. Patients were referred to the LMHS
(Licking Memorial Health Systems) Outpatient Medication Therapy Insulin Clinic by their physician during the time periods of July
2012 through March 2013 and August 2014 through December 2014. Physician authorization permitted pharmacists to provide clinical
monitoring in order to evaluate and adjust insulin, GLP-1 agonist and amylin mimetic doses by adhering to approved dosing guidelines
and policy and procedures. Hemoglobin A1c values were obtained from the patients electronic medical records. Patients achieved an
average decrease in HbA1c of 0.8 percentage points over a mean of 83 days. Pharmacist insulin management is an innovative pharmacy
service through which clinical pharmacists can have an impact on patients’ HbA1c.

Key words: Pharmacist, diabetes, insulin management.

1. Introduction complications associated with diabetes [4].

Macrovascular complications include coronary artery
According to the ADA (American diabetes
disease, peripheral artery disease and stroke. It has
association) 2014 guidelines, diabetes is diagnosed by
been shown that reducing HbA1c by 0.8% can reduce
one of the following: HbA1c (hemoglobin A1c) of 6.5%
the risk of cardiovascular death by 45% [5]. It is
or greater, fasting plasma glucose of 126 mg/dL or
evident that glycemic control in diabetics is very
greater, two hour post oral glucose tolerance test
important for each patient. Several studies have
plasma glucose of 200 mg/dL or greater, or in a patient
demonstrated the benefit of glycemic control through
with a random glucose of 200mg/dL or greater
pharmacist intervention [6-10]. This study originated
presenting with symptoms of hyperglycemia or
as a way to justify pharmacist involvement with
hyperglycemic crisis. The goal HbA1c in diabetic
diabetes management. Due to the broad nature of the
patients is less than 7% per ADA guidelines [1].
disease state, it was collectively decided to narrow the
Initiation of an oral diabetic medication will provide a
focus to insulin and other injectable agents and not
decrease in HbA1c of 1–1.25% over the first 3-6 months
include adjusting oral diabetic medications. The idea
[2].
was to collect information to hopefully demonstrate
Uncontrolled diabetes can lead to long-term
positive results that could be used for future promotion
complications of the microvascular and macrovascular
of Clinic services.
system. Microvascular complications include diabetic
The primary outcome was to evaluate glycemic
nephropathy, neuropathy and retinopathy. Diabetic
control in patients requiring insulin therapy through
nephropathy is the leading cause of chronic kidney
close monitoring and routine follow up with
disease in patients starting dialysis [3]. Diabetic
pharmacists. This was measured by assessing the
retinopathy is one of the most common microvascular
average change in HbA1c following pharmacist
Corresponding author: Danette Warner, Pharm.D., BCPS, intervention. The secondary outcomes were to measure
Department of Pharmacy, Licking Memorial Health System,
1320 W. Main St., Newark 43055, OH. Email:
the change in: weight over first follow-up period,
dwarner@lmhealth.org.
360 Impact of Pharmacist Insulin Management on Hemoglobin A1c in Outpatient Hospital Clinic Setting
HbA1c over the second follow-up period, HbA1c prior
to initial Clinic visit, and HbA1c with physician
management compared to pharmacist management.
2. Methods
2.1 Clinic Description
LMHS (licking memorial health systems) is a
not-for-profit healthcare organization dedicated to the
mission of improving the health of the community. The
Health Systems includes a 227-bed inpatient facility in
addition to a professional corporation including a
group of 100-plus physicians in various practices
throughout Licking County. Over 5,000 patients within
LMHS have been diagnosed with diabetes, which is
nearly 15% of the patients of the LMHS patient
population.
An LMHS primary care physician requested that
diabetes management be incorporated into the
established MTC (medication therapy clinic) where
pharmacists provide medication management for
anticoagulation therapy and patients with anemia and
heart failure. Diabetes management was initially
designed to help reduce hospital re-admissions,
improve communication during transitions of care and
provide more frequent monitoring of glucose readings
by pharmacists. An endocrinologist accepted the role
of medical director and created clearly defined
guidelines and algorithms for dosing insulin, GLP-1
(glucagon-like peptide-1) agonist, and amylin
mimetics utilizing ADA guidelines [1]. These
guidelines (Fig. 1) and all Clinic policies and
procedures were approved by the P&T (pharmacy and
therapeutics) and medical executive committees [1].
Clinic pharmacists underwent specialized training and
obtained diabetes management certification. Signed
physician referral forms received via EMR (electronic
medical record) or fax included orders for pharmacist
management based on these established guidelines.
The referral forms included authorization to evaluate
the need for CGM (continuous glucose monitors), basic
laboratory standing orders, and referrals for DSMT
(diabetes self-management training) or MNT (medical
nutrition therapy). Referrals to the Clinic were limited
to patients on insulin therapy, GLP-1 agonist or amylin
mimetics. The goal was to achieve HbA1c reductions
through closer monitoring allowing more frequent
opportunities for dose adjustments following approved
guidelines and algorithms. In order to evaluate the
effectiveness of this model, HbA1c results were tracked
during the course of treatment.
2.2 Intervention
Clinic visits were given designated time frames of 60
minutes for initial Clinic visits and 30 minutes for
follow-up visits. The Clinic was staffed with a nurse
and pharmacist. At each Clinic visit, physical
assessments were performed which included weight
and vital signs (blood pressure and pulse). Patients
were interviewed at every visit and asked about their
diet, physical activity, signs and symptoms of low
blood sugar, if experienced, and how the patient treated
their low blood sugar levels. Patients were educated on
use of insulin, how and where to inject insulin and
possible side effects. Patients were instructed to bring
SMBG (self-monitoring blood glucose) logs or their
blood glucose meter to each Clinic appointment for
review. Pharmacists assessed glucose logs or readings
from the patient’s meter and made appropriate insulin
dosing changes based on the approved guidelines.
Pharmacists were approved to make dose adjustments
to patients’ injectable diabetes medications per signed
Clinic referral forms. All orders and insulin dosage
adjustments were written according to the Insulin
Management Policy and Procedure Dosing Guidelines,
documented in the EMR (electronic medical record)
and then reviewed and signed by the supervising
physician. A pharmacist and each patient worked
together in setting individualized goals for follow-up
appointments. Follow-up appointments were scheduled
approximately every 4-6 weeks depending on the
patient’s response to and adherence with treatment.
In between Clinic visits, patients were asked to submit
 Impact of Pharmacist Insulin Management on Hemoglobin A1c in Outpatient Hospital Clinic Setting 361

Clinic Dosing Guidelines

Insulin Dosing Step 1: Target Fasting Plasma Glucose (FPG) with Basal Insulin.
FPG Target= 80/130 mg/dL*
Bedtime Basal Insulin - start with 10 units or 0.2 units/kg.
Increase dose by 2 units every 3 days until FPG is 80-130 mg/dL.*
May increase by 4 units every 3 days if FPG is > 180 mg/dL.*
*Glucose targets should be individualized based on patient co-morbidities, patient needs, and response to blood
glucose lowering.

Insulin Dosing Step 2: If blood sugar not controlled after FPG target is reached or if basal insulin dose > 0.5
units/kg/day, treat post-prandial glucose with mealtime insulin or GLP-1 agonist.
Option 1: Add a rapid-acting insulin injection before largest meal.
•Start: 4 U, 0.1 units/kg, or 10% of basal insulin dose. If HbA1c < 8%, consider decrease in basal insulin dose by same
amount.
•Titration: Increase dose by 1-2 units or 10-15% one to two times weekly until SMBG target reached.
•For Hypoglycemia: Determine and address cause; decrease corresponding insulin dose by 2-4 units or 10-20%.
Option 2: Change to premixed insulin twice daily.
•Start: Divide current basal dose into 2/3 AM, 1/3 PM or 1/2 AM, 1/2 PM.
•Titration: Increase dose by 1-2 units or 10-15% one to two times weekly until individualized target achieved.
•For Hypoglycemia: Determine and address cause; decrease corresponding insulin dose by 2-4 units or 10-20%.
Insulin Dosing Step 3: If A1c not at goal: Add 2 or more rapid-acting insulin injections before meals (basal-bolus
dosing).
• Start: 4 units, 0.1 units/kg, or 10% basal dose/meal. If A1c < 8% consider decreasing the basal by same amount.
• Titration: Increase dose by 1-2 units or 10-15% once-twice weekly until SMBG target reached.
• For Hypoglycemia: Determine and address cause; decrease corresponding insulin dose by 2-4 units or 10-20%.

Bolus Insulin Dosing Correction Factor:

•Add 1 unit for every 50 mg/dL blood sugar is above 150 mg/dL.
•Decrease by 2 units for blood sugar less than 80 mg/dL.

Other Injectable Diabetes Medication:

•GLP-1 agonist and amylin mimetic - Titrate based on manufacturer recommendations.

Fig. 1 Clinic Dosing Guidelines: Approved by P&T and medical executive committees [1].

glucose logs every 2-4 weeks for evaluation by the 2.3 Patient Selection
pharmacists. Patients were contacted by telephone to This retrospective chart review was completed for a
discuss glucose logs and given dosing instructions over total of 49 patients who were referred for an initial
the phone. Phone visits also were documented in the Clinic visit at the LMHS MTC by their endocrinologist
EMR and routed to the supervising clinician for (n = 36) or primary care physician (n = 13) during the
signature. Hypoglycemia is a significant risk factor designated time periods of the study: July 2012 to
when adjusting insulin therapy. Institutional ED March 2013 and August 2014 to December 2014.
(emergency department) visits and inpatient Several factors attributed to retrospectively reviewing
admissions were monitored and tracked for two discontinuous time periods. The initial period
hypoglycemic events through the EMR. served as a pilot period allowing staff training and
362 Impact of Pharmacist Insulin Management on Hemoglobin A1c in Outpatient Hospital Clinic Setting
education while working closely with an
endocrinologist in the office. The gap in-between study
periods was used to set up services within the Clinic
setting. This time period also included Clinic relocation
and staffing changes which were not conducive to
initiating additional Clinic services. During the first
time period of the study, pharmacists managed patients
in the endocrinology office to pilot the program. Once
the Clinic relocation was complete and the billing
process was set up, the pharmacists began managing
patients within the Clinic during the second time period.
Follow-up data collection after conclusion of the study
was extended through April 2015. Approval for chart
review was obtained from the P&T (Pharmacy and
Therapeutics) committee. This study was not submitted
for Institutional Review Board approval. A pharmacy
student provided comprehensive chart review and
collection of all data for the study. Patients were
excluded from the study if they did not attend the initial
Clinic visit or a second follow-up visit. Patients were
included in the study if their baseline HbA1c was within
12 weeks before or 4 weeks after their initial Clinic
visit and the first follow-up HbA1c was drawn within
4-20 weeks following their initial Clinic visit. HbA1c
tests were ordered by the referring physician and
results reviewed from the EMR.
For the second follow-up change in HbA1c patients
were excluded if they did not have a HbA1c that fell
within 12-20 weeks after previous HbA1c from first
follow-up visit. Patients were excluded from the
assessment of change HbA1c prior to initial Clinic visit
if their HbA1c was not drawn within 20 weeks prior to
the initial Clinic visit. Those who had a HbA1c within
20 weeks prior to the initial Clinic visit were then
compared to their first follow-up change in HbA1c.
2.4 Statistical Analysis
Statistical analyses were conducted using the paired
t-test for the primary outcome and the secondary
outcomes of mean change in weight at the first
follow-up and HbA1c at second follow-up. A
non-paired t-test was used to evaluate the secondary
outcome that assessed the change in HbA1c of insulin
management by the Clinic pharmacists compared to
physician managed prior to Clinic. Statistical
significance was concluded with a p-value less than
0.05.
3. Results
A total of 49 patients were referred to the Insulin
Clinic during the designated time period of the study.
Of the 49 patients referred, 35 met the inclusion criteria
for the primary outcome as shown in Fig. 2. The
baseline demographics of the 35 patients are provided
in Table 1 and their diabetic treatment regimens are
shown in Table 2.
The primary outcome was the change in HbA1c from
baseline at initial Clinic visit to the first follow-up visit.
The baseline HbA1c average for the 35 Clinic patients
was 9.5%. The average time period between initial
Clinic visit and first follow-up HbA1c was 83 (28 to 140)
days. During the first follow-up period, the change in
HbA1c ranged from a 5.7% decrease to a 1.8% increase.
The average HbA1c at first follow-up was 8.7%,
resulting in an average reduction of 0.8% (p = 0.015).
Of the 35 patients, 24 of them had a decrease in HbA1c.
The 35 Clinic patients included in the primary
outcome of the study had an average increase in weight
of two pounds (p = 0.279) over the 83 day average
during the first follow-up period.
After assessment of first follow-up, a second
follow-up HbA1c was evaluated. Only 17 of the 35
patients had a HbA1c that was 12-20 weeks after the
previous HbA1c from the first follow-up. Amongst the
17 patients included in the second follow-up, nine
patients had a decrease in HbA1c. Overall, the average
change in HbA1c was 0% (p = 0.967). The results
ranged from a 2.5% decrease to a 2.2% increase for the
second follow-up in HbA1c.
To assess the change in HbA1c prior to initial Clinic
visit a HbA1c within 20 weeks prior to initial Clinic
visit was used. Of the 35 patients included in the study,
 Impa
act of Pharma
acist Insulin Management
M on Hemoglobin A1c in Ou
utpatient Hosp
pital Clinic Se
etting 3633

49 referaals

35 inncluded 14 excluded

9 never
5 patients
24 folllowed
11 incrrease no showed
decrease upp after
in HbA A1c to first
i HbA1c
in innitial
clinic visit
clinnic visit
Fig. 2 Inclussion and exclusion criteria.

Table 1 Basseline Demograaphics (n = 35)). visiit was compaared to the ffirst follow-u up change inn
Males (n) 144 (40%) HbA A1c in order too evaluate diaabetes manag
gement by thee
Females (n) 211 (60%) phaarmacists verrsus the mannagement by the PCP orr
Average Age (years) 577 (35-84)
end
docrinologist prior to com ming to the Clinic. Thiss
Average Baseeline HbA1c (%
%) 9.5 (6.6-14.2)
Baseline HbAA1c ≤ 7.5% (n) 7 (20%)
com
mparison incluuded the 30 ppatients who had a HbA1cc
Average BMII (kg/m2) 400.1 (20-61) withhin 20 weekss prior to theeir initial Clin
nic visit. Thee
Type 1 Diabeetic (n) 3 (9%) aveerage change in HbA1c off diabetes man nagement byy
Type 2 Diabeetic (n) 322 (91%) the PCP or endoocrinologist w was 0.1% inccrease. Thesee
Referred by Endocrinologist
E t (n) 266 (74%)
30 patients
p had a change in HHbA1c of 0.7% % decrease att
Referred by PCP
P (n) 9 (26%)
the first follow-uup through phharmacist maanagement.
Table 2 Diabetic treatmen
nt regimens. Patient
P ED annd inpatient addmissions weere monitoredd
Basal Insulin (n) 4 (11%) and
d evaluated for
f hypoglyccemic events. During thee
Basal-Bolus (n)
( 288 (80%)
designated timee frame pharrmacists mad
de 134 dosee
Mix (n) 2 (6%)
U-500 Insulinn (n) 1 (3%) ustments andd only 1 patient had an id
adju dentified ED
D
GLP-1 Agoniist (n) 4 (11%) adm
mission for hyypoglycemia. This patient was treatedd
Symlin (n) 2 (6%) and
d released witthout being admitted and no
n additionall
Oral Antidiabbetics (n) 200 (57%) inpaatient admisssions were identified during postt
30 of them had
h a HbA1c that t was withiin 20 weeks prior p anaalysis chart review.
to initial Cliinic visit. Ovver an averagge of 99 (34-133)
4. Discussion
D
days prior too initial Cliniic visit, the 30 patients haad an
average incrrease of 0.1% % (p = 0.7988), which rannged The
T results off the 35 patieents included
d in the studyy
from 2.7% decrease
d to 2.7%
2 increasee, under diabbetes for managemennt of injectabble diabetes medicationss
management with their PCP P or endocrrinologist. werre evaluated to
t determine the impact off pharmacistss
Lastly, thee change in HbA
H 1c prior too the initial Cllinic on diabetic
d care. This study demonstrated
d that closelyy
364 Impact of Pharmacist Insulin Management on Hemoglobin A1c in Outpatient Hospital Clinic Setting
Table 3 Statistical results of study outcomes.
OUTCOMES
Change in HbA1c at first follow-up (n = 35)
Change in weight in first follow-up period (n = 35)
Change in HbA1c at second follow-up (n = 17)
Change in HbA1c prior to initial Clinic visit (n = 30)
Endocrinologist/PCP versus Pharmacist Clinic (n = 30)
monitored patient care provided by a pharmacist
directly resulted in a statistically significant 0.8
percentage point reduction in HbA1c over an average
83 day period. All patients in the study had diabetes
care provided by their PCP or endocrinologist prior to
their referral to the Clinic. Achieving significant HbA1c
reductions in this group of previously managed patients
only strengthens the primary outcome of this study.
The introduction of new medication therapy often has
the greatest impact on improving disease state
management. This holds true with diabetes, as the
initiation of an oral agent provides an important HbA1c
reduction within the first 3-6 months of beginning
treatment. This study produced nearly the same
reduction in HbA1c in a shorter time period only by
improving current therapy as opposed to adding new
therapy. Upon presentation to initial Clinic visit, 20%
of patients had a baseline HbA1c less than or equal to
7.5% which showed that maintaining glycemic control
was just as important as decreasing HbA1c. At first
follow-up, 69% of the 35 patients had a reduction in
HbA1c.
Secondary outcomes also were evaluated and the
results were not statistically significant. A small
increase in weight was identified in the first follow-up
period. Weight gain is a common adverse effect of
insulin therapy which was an anticipated outcome.
Results from a second follow-up were obtained to
determine if a further reduction in HbA1c were
achieved and no change in HbA1c was noted after an
additional 12-20 week time period. The lack of
difference between results demonstrates stability with
extended pharmacist management beyond the first
follow-up period. Unfortunately, less than half of the
RESULTS P-VALUE (95% CI)
-0.8% 0.015 (0.160-1.388)
2 pounds 0.279 (-5.53-1.65)
0% 0.967 (-0.587-0.563)
0.1% 0.798 (-0.506-0.932)
0.1% vs-0.7% 0.068 (-0.056-1.509)
patients had results reported within the designated time
period. Also, HbA1c readings within 20 weeks prior to
the initial baseline HbA1c were evaluated. It was
confirmed that patients were stable and mostly
unchanged prior to initial Clinic referral as a slight
increase was noted during this time of physician
management. The HbA1c changes between physician
and pharmacist time periods were compared and the
pharmacist’s reduction further demonstrated the
clinical importance of the results obtained in this study.
Numerous studies have shown the benefit of having
pharmacists as a part of the healthcare team in relation
to treating patients with diabetes. In these studies,
pharmacists were able to help manage diabetes
regardless of the patient’s medication profile.
Pharmacists were able to serve a more active role in the
management of diabetic medications through initiating
and adjusting both oral and injectable medications in
these studies.6-10 This study demonstrates the impact
that pharmacists can have through management of only
injectable diabetic medications. HbA1c reductions were
obtained through close monitoring and follow-up of
glucose readings, conservative dosing guidelines and
protocols, and direct pharmacist to patient interactions.
Limitations were identified in this study. First off,
patients were encouraged to document glucose
readings, insulin dosing, as well as basic dietary
information and report these details to the Clinic. This
was done in a variety of ways and often was
inconsistent in limiting the ability to make appropriate
therapy modifications. With future studies, a more
consistent approach utilizing electronic technology to
download current glucometer results would be
beneficial. Also, having complete autonomy with
 Impact of Pharmacist Insulin Management on Hemoglobin A1c in Outpatient Hospital Clinic Setting
HbA1c orders would narrow the timeframe between
tests, allowing for more comparable results. Using a
point-of-care device in conjunction with appointments
would efficiently allow for quicker results and could
contribute to improved visit compliance. Weights were
recorded using different scales as some results were
obtained by a combination of chart review and Clinic
visits. This made it difficult to have a true measurement
of weight change. Reviewing hypoglycemic events
was limited to one health system. However, LMHS
includes the only hospital and ED in the remote area as
well as two urgent care facilities. It is reasonable that
patients could have elected to have care provided
outside of LMHS as two patients lived outside of the
county.
5. Conclusion
Diabetes is a prevalent disease state that can lead to
many devastating complications in patients with
uncontrolled diabetes. Glycemic control can decrease
the rates of cardiovascular disease and macrovascular
and microvascular complications. Therefore, the
importance of managing and controlling diabetes
cannot be understated. Pharmacists play a vital role in
improving the management of insulin and should be
utilized routinely in patient-centered diabetes care.
References
[1] American Diabetes Association. 2014. “Executive
Summary: Standards of Medical Care in Dabetes 2014.”
365
Diabetes Care 37 Suppl 1: S5-13.
[2] Sherifali, D., Nerenberg, K., Pullenayegum, E., et al. 2010.
“The Effect of Oral Antidiabetic Agents on A1c Levels: A
Systematic Review and Meta-analysis.” Diabetes Care 33
(8): 1859-64.
[3] Gross, J. L., de Azevedo, M. J., Silveiro, S. P., et al 2005.
“Diabetic Nephropathy: Diagnosis, Prevention, and
Treatment.” Diabetes Care 28 (1): 164-76.
[4] Fowler, M. 2008. “Microvascular and Macrovascular
Complications of Diabetes.” Clinical Diabetes 26 (2):
77-82.
[5] Diabetes in Control [Internet]. 2012. “ADA: Reducing
A1c a Little Less than 1 Point Reduces CV Risk by
45Percent.” Cardiovascular Health 631. Accessed
January 14, 2016.
http://www.diabetesincontrol.com/ada-reducing-a1c-a-litt
le-less-than-1-point-reduces-cv-risk-by-45-percent.
[6] Jacobs, M., Sherry, P. S., Taylor, L. M., et al. 2012.
“Pharmacist Assisted Medication Program Enhancing the
Regulation of Diabetes (PAMPERED) Study.” J. Am.
Pharm. Assoc. 52 (5): 613-21.
[7] Wallgren, S., Berry-Cabán, C. S., and Bowers, L. 2012.
“Impact of Clinical Pharmacist Intervention on
Diabetes-Related Outcomes in a Military Treatment
Facility.” Ann Pharmacother 46 (3): 353-7.
[8] Cranor, C. W., Bunting, B. A., and Christensen, D. B.
2013. “The Asheville Project: Long-Term Clinical
and Economic Outcomes of a Community Pharmacy
Diabetes Care Program.” J. Am. Pharm. Assoc. 43 (2):
173-84.
[9] Hassali, M. A., Nazir, S. U., Saleem, F., et al. 2015.
“Literature Review: Pharmacists’ Interventions to
Improve Control and Management in Type 2 Diabetes
Mellitus.” Altern. Ther. Health Med. 21 (1): 28-35.
[10] Collier, I. A., and Baker, D. M. 2014. “Implementation of
a Pharmacist-Supervised Outpatient Diabetes Treatment
Clinic.” Am. J. Health Syst. Pharm. 71 (1): 27-36.